Sterility Testing

Merck Millipore has developed sterility tests for 40 years, amassing great experience in offering various solutions for testing product sterility. This includes specialized devices with various personally-tailored adapters for different packaging. The company also provides solutions for testing products with antimicrobial activity and products that are ordinarily difficult to filter. In addition, the company supplies IQ/OQ validation services and PQ support, as well as a variety of sterile mediums and detergents for testing purposes.

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Sterility Testing

Direct Inoculation Method

Autoclave Control

Sterikon® ampoules allow efficient testing of the autoclave sterilization process. These ampoules contain several bacterial strains and a growth medium. The ampoule is inserted into the autoclave together with materials intended for sterilization, and at the end of the sterilization cycle they are transferred to an incubator. If there is no growth, you can be sure that the autoclave is working effectively.

Culture Media & Rinsing Fluids

Growth substrates and detergents for sterile testing from Merck Millipore are produced to the highest standard ISO-9001 compliant manufacturing facilities, with each batch tested according to the requirements of the European, American and Japanese pharmacopeia. The solution is packed in glass bottles of different volumes with septum stoppers. The bottles can be ordered in double packs.

Membrane Filtration Sterility Test

Rapid Detection Methods for Sterility

The latest development from Merck Millipore allows for a considerable reduction in sterile testing time. Today, classical methods require a long 14-day incubation, which is a significant time for batch release. The use of rapid new technology based on ATP detection has shortened the necessary time to just 5 days! The method has been FDA-tested and is already used by several major pharmaceutical companies.

Sterility Testing Hardware

Steritest™ Symbio Pumps The next generation of sterility testing pumps The new Symbio pumps are designed to suit your work environment, with several designs and models dedicated to flow hood, isolator and clean room testing. A computer program that allows the transfer of 250 pump protocols accompanies the various testing stages step by step, with a low pump design offering the user greater comfort. The pump head, drip tray and tube are removable and sterilized in the autoclave. The bottle holder has an adjustable height. The pump head closes automatically and allows rapid input from the pipes while also ensuring equal distribution of fluid between the pipes. In addition, it prevents tearing of gloves in the event they are snagged by the head. The pump is equipped with a timer that allows the pump’s movement to be repeated and paused for short periods of time (good for products with small volume, prevents air from entering). The pump pressure control mechanism gives an a

Industrial Microbiology